Underrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-03-15 06:30 (424 d 12:52 ago) – Posting: # 21272
Views: 3,407

Hi,

» Can we conduct the pivotal study only in Males? Can we extrapolate the conclusions obtained in males to females. What would be the regulatory challenges and please prove some references that can guide me on this.

FDA? Even if not FDA I don't think your justification will work. You are trying not to use female subjects because they caused your study to fail. That alone is not a good justification.

J

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